Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Adults

NCT ID: NCT01745380

Last Updated: 2017-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-05-31

Brief Summary

The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.

Detailed Description

The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure. The maxillary teeth will be categorized in two subsets, anteriors (teeth numbers 6 to 11) and premolars (teeth numbers 4, 5, 12 and 13).

The intent is to treat 150 subjects at 3 study sites, 2:1 randomization within each study site, and an overall goal of 100 subjects treated with Kovacaine Mist and 50 treated with placebo. Recruitment will be from diverse dental patient populations with at least 25% of subjects over 50 years of age. Randomization will be within strata defined by age (≤50 and >50 years).

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Kovacaine Mist

Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.

Group Type: EXPERIMENTAL

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Intervention Type: DRUG

The study drug is regional anesthetic delivered intranasally on the same side as the operative tooth

Placebo

Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The placebo spray was identical in appearance to and was administered in the same volume and manner as the active ingredient.

Interventions

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

The study drug is regional anesthetic delivered intranasally on the same side as the operative tooth

Intervention Type: DRUG

Placebo

The placebo spray was identical in appearance to and was administered in the same volume and manner as the active ingredient.

Intervention Type: DRUG

Other Intervention Names

Kovacaine Mist; inactive ingredients

Eligibility Criteria

Inclusion Criteria

• Male or female 18 years of age or older.
• Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (anterior or premolar tooth #4 to #13) with no evidence of pulpal pathology.
• Normal lip, nose, eyelid, and cheek sensation.
• Able to understand and sign the study informed consent document, communicate with the Investigators, and understand and comply with the requirements of the protocol.
• Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure (the treatment tooth).
• Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
• Seated systolic blood pressure (SBP) between 95 and 150 mm Hg, inclusive, and seated diastolic blood pressure (DBP) between 60 and 100 mm Hg, inclusive.

Exclusion Criteria

• Inadequately controlled hypertension (blood pressure greater than 150/100 mm Hg).
• Inadequately controlled active thyroid disease of any type.
• Frequent nose bleeds (≥ 5 per month).
• Having received dental care requiring a local anesthetic within the 24 hours preceding study entry.
• History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
• History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives.
• Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.
• Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)
• Having received any investigational drug and/or participation in any clinical trial within the 30 days prior to study participation.
• History of congenital or idiopathic methemoglobinemia.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Triligent International

INDUSTRY

Sponsor Role: collaborator

Rho, Inc.

INDUSTRY

Sponsor Role: collaborator

St. Renatus, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Center for Dental Research Loma Linda University School

Loma Linda, California, United States

University of Maryland, Baltimore

Baltimore, Maryland, United States

University of Pennsylvania, School of Dental Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

SR 3-03

Identifier Type: -

Identifier Source: org_study_id